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EU restrictions could potentially ban more than 10,000 PFAS with wide-ranging effects on industries

As per- and polyfluoroalkyl substances (PFAS) regulations proliferate regionally, global markets and supply chains are spreading their impacts to product manufacturers and other stakeholders around the world. The effects of the European Union's 2023 restriction proposal, , is already being felt in the U.S., where some companies have lost EU suppliers who stopped manufacturing or exporting PFAS-containing products in preparation for pending restrictions.

While its full effects remain to be seen, the EU's 2023 restriction proposal could potentially ban more than 10,000 PFAS. Specifically, the proposal — under the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation — may prohibit PFAS from being manufactured, used, placed on the market, or added to another substance, whether as a constituent or as a mixture, or in an article, in a concentration of or exceeding the following values: 

• 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification) 
• 250 ppb for the sum of PFAS measured as sum of targeted PFAS analysis, optionally with prior degradation of precursors (polymeric PFAS excluded from quantification) 
• 50 ppm for PFASs (polymeric PFASs included)

The EU has already applied these same limits to sustainable packaging through the recently adopted Packaging & Packaging Waste Regulation (PPWR), which entered into force  and will apply uniformly across all 27 EU member states in 18 months.

Charting a PFAS strategy now is critical for stakeholders across many industries.

Proposed timeline for the EU's PFAS restriction proposal

The 2023 restriction proposal, spearheaded by five EU Member States (Denmark, Germany, Sweden, the Netherlands, and Norway), is now undergoing a rigorous, multi-year evaluation by the European Chemicals Agency's (ECHA) Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC), who are responsible for delivering a final opinion to the European Commission. 

To date,  and are discussing the potential impact of the restrictions on 15 industries following this approximate timeline:

• 2026: RAC and SEAC to conclude evaluation of restriction proposals by industry 
• 2027: European Commission and EU member countries will make the final decision on proposed restrictions 
• 2028/2029: Restriction enters into force

Eighteen months after entering into force, the EU restriction proposal is anticipated to establish different scenarios for different industries: either an immediate ban or a ban with a derogation period of 5 or 12 years, allowing time for stakeholders to identify alternatives to PFAS. Some sectors — such as cosmetics, home textiles, consumer apparel, consumer cookware, consumer mixtures, and electronics — are listed as potential candidates for an immediate PFAS ban. This may be because these are industries where it is believed that alternatives to PFAS already exist or will exist by the time the ban takes effect, but this could change if no alternatives are found. 

Despite the uncertainty surrounding which sectors will be subject to a full or partial ban, and on what timeline, companies can start preparing for the EU restrictions by developing a PFAS management strategy. This can be accomplished by first determining the level of PFAS, if any, currently in their products — either intentionally as an ingredient or unintentionally through contamination; conducting supply chain audits to identify possible unintentional sources of PFAS at each point in the supply chain; sourcing and investing in alternatives to PFAS; and staying current on the latest requirements for regulatory compliance. 

Different regulatory approaches to PFAS

In developing a PFAS strategy, stakeholders in the EU can draw on lessons from their counterparts in the U.S., where PFAS regulations have evolved at a quicker pace, although the regulatory landscape for PFAS is more disparate than in the EU due to the creation of both federal and state regulations.

At the federal level, the U.S. Environmental Protection Agency (EPA) has issued a ""; established regulations for drinking water establishing maximum contaminant levels; and implemented required reporting related to the manufacture and import of PFAS over a 10-year period and certain aspects of contaminated land management. At the same time, many U.S. states have passed PFAS regulations that outline restrictions and reporting requirements that apply to products and applications that include PFAS; however, these regulations differ from one state to another and use different definitions of "PFAS," amounting to a complex patchwork of requirements for companies to navigate.

Unlike the U.S., the EU is taking a more centralized approach that encompasses multiple industries. After seeking input in 2023, the restriction proposal received over  from more than 4,400 organizations, companies, and individuals representing industries from aerospace and automotive to pharmaceuticals and personal electronics. ECHA states it is reviewing each of these comments.

Similar regulatory challenges for PFAS

Essential uses

Despite differences in their regulatory approaches, the EU and U.S. face similar challenges. Both are struggling to define "essential use" of PFAS, a designation which is expected to exempt some PFAS applications from regulation in certain contexts or to extend their timeline for compliance. The U.S. Chamber of Commerce has attempted to define essential uses of PFAS  — along with the potential impact of the loss of these essential uses on the national economy — in seven industries: vehicles, semiconductor manufacturing, data centers, energy transition and emerging energy technologies (solar panels, wind turbine towers and blades, and subcomponents of lithium-ion batteries), defense, healthcare, and aerospace manufacturing. 

Non-standardized testing

U.S. state regulations sometimes cover very small amounts of PFAS, in the parts per million range; however, those amounts can vary, and the testing methods associated with those limits are not standardized. Different labs may produce different results, in part because the methods used to obtain the test results differ in analytical detection methods and approaches to sample preparation. Companies may face similar challenges in the EU, where testing has yet to be standardized or made widely accessible. Given the current lack of standardization, it is especially important to understand the testing options available, the accuracy and the usefulness of the data they generate, and their potential impacts on risk assessments and decision making.

Supply chain contamination

For those companies with complex, multi-layer supply chains that involve hundreds of global vendors, there are numerous points in the product lifecycle where PFAS may be intentionally or unintentionally introduced. As a result, knowing whether PFAS is in a supply chain can be challenging for manufacturers, especially if the components they are using have been manufactured in locations like Asia, where the general use of certain chemicals that have been phased out in the U.S. and EU (including some PFAS) is still permitted.

Unfit-for-purpose alternatives to PFAS

While stakeholders in the EU and U.S. are in the , potential replacement candidates present their own challenges. Some alternatives to PFAS in certain applications may be restricted under other regulations, such as CFCs, HFCs, and some other chemicals used in refrigerant and propellant applications that are already being phased out over concerns about greenhouse gases. In food packaging, some PFAS alternatives also require regulatory compliance/clearance, which can be challenging and take months or even years to obtain. For new or untested chemistries, there is the risk that the alternatives could present unacceptable risks for human health and the environment.

Another difficulty across industries is that many alternatives do not perform as well or have the same characteristics as the PFAS-containing version of the products. Although acceptable replacements can sometimes be identified that use larger quantities or mixtures of non-fluorinated chemicals or materials, there are few one-to-one replacements available, and product performance may not equal what was possible using PFAS.

For example, food packaging made from coatings using starch and . In addition, the cost of manufacturing alternatives can be expensive and more time-consuming than using PFAS, slowing down production and increasing costs, so it is possible that alternatives could create a poor performing, more costly product that is not commercially viable.

Defining a course of action

Given the time required to identify, analyze, and replace PFAS in products, charting a PFAS strategy now is critical for stakeholders across many industries. Companies can begin to identify unintentional PFAS sources — along with confirming intentionally used PFAS — by designing an approach for assessing PFAS in past and present supply chains, finished goods, and waste streams. If products do contain PFAS, knowing whether levels are above or below threshold limits is essential. Equally important is knowing where and how PFAS may be entering products through the manufacturing process, such as from PFAS-containing grease on conveyor belts coming into contact with food stuffs and getting into food packaging. 

Some key actions that industries can take include:

• Mapping the operational process  to identify known and unknown sources and uses of PFAS; uncover knowledge gaps regarding materials used in products and processes, as well as any variability in material sourcing; develop a strategy for filling those gaps; and design customized testing plans and sample preparations to determine whether products contain PFAS or meet threshold limits. 
• Performing toxicological, environmental, or supply chain risk assessments to uncover intentional and unintentional sources of PFAS as well as the extent of potential toxicity and the likelihood of exposure to consumers or the environment. For example, the use of migration testing in food material packaging risk assessments can determine the likelihood of the extent of exposure to consumers.
• Securing compliance for PFAS alternatives through compliance testing; fit-for-purpose and performance assessments of alternatives; and communicating the benefits of alternatives to regulatory bodies, insurers, corporations, and other interested entities.